Another addition to Amneal’s growing complex injectables portfolio reflects leadership in advanced development and manufacturing of complex pharmaceuticals BRIDGEWATER, N.J., Sept. 04, 2025 (GLOBE NEWSWIRE) -- Amneal Pharmaceuticals, Inc. (“Amneal” or the “Company”) today announced the U.S. Food and Drug Administration (FDA) approval of risperidone extended-release injectable suspension 12.5 mg/vial, 25 mg/vial, 37.5 mg/vial and 50 mg/vial, which references Janssen’s Risperdal Consta®. The product is eligib ...

Shares of Amneal Pharmaceuticals (AMRX) have gained 22.1% over the past four weeks to close the last trading session at $9.56, but there could still be a solid upside left in the stock if short-term price targets of Wall Street analysts are any indication. Going by the price targets, the mean estimate of $12 indicates a potential upside of 25.5%.The mean estimate comprises four short-term price targets with a standard deviation of $0.82. While the lowest estimate of $11.00 indicates a 15.1% increase from th ...

Core Viewpoint - Amneal Pharmaceuticals (AMRX) has shown a significant price increase of 13.8% over the past four weeks, with a mean price target of $12 indicating a potential upside of 27.7% from its current price of $9.4 [1] Price Targets and Analyst Consensus - The average price target for AMRX ranges from a low of $11.00 to a high of $13.00, with a standard deviation of $0.82, suggesting a relatively tight clustering of estimates [2] - The lowest estimate indicates a 17% increase from the current price, while the highest estimate points to a 38.3% upside [2] - A low standard deviation indicates strong agreement among analysts regarding the stock's price movement direction [9] Earnings Estimates and Market Sentiment - Analysts have shown increasing optimism about AMRX's earnings prospects, as evidenced by a positive trend in earnings estimate revisions [11] - Over the last 30 days, the Zacks Consensus Estimate for the current year has increased by 8.9%, with three estimates moving higher and no negative revisions [12] - AMRX holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimates [13] Implications of Price Targets - While the consensus price target may not be a reliable indicator of the stock's potential gain, it does provide a directional guide for further research [14]

Core Viewpoint - The article emphasizes the importance of identifying and sustaining stock price trends for successful short-term investing, highlighting the need for strong fundamentals and positive earnings revisions to maintain momentum [1][2]. Group 1: Stock Performance - Amneal Pharmaceuticals (AMRX) has shown a solid price increase of 21.6% over the past 12 weeks, indicating investor confidence in its potential upside [4]. - The stock has also increased by 9.1% over the last four weeks, suggesting that the upward trend is still intact [5]. - AMRX is currently trading at 83.5% of its 52-week high-low range, indicating a potential breakout opportunity [5]. Group 2: Fundamental Strength - AMRX holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimate revisions and EPS surprises [6]. - The stock has an Average Broker Recommendation of 1 (Strong Buy), reflecting high optimism from the brokerage community regarding its near-term price performance [7]. Group 3: Investment Strategy - The article suggests that investors can utilize the "Recent Price Strength" screen to identify stocks like AMRX that are on an upward trend supported by strong fundamentals [3][8]. - It also mentions the availability of over 45 Zacks Premium Screens tailored to different investing styles, which can help in finding winning stock picks [8].

[PART I - FINANCIAL INFORMATION](index=6&type=section&id=PART%20I%20-%20FINANCIAL%20INFORMATION) This section covers the company's unaudited financial statements, management's discussion and analysis, market risk disclosures, and internal controls for the period ended June 30, 2025 [Item 1. Financial Statements (Unaudited)](index=6&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) This section presents Amneal Pharmaceuticals' unaudited consolidated financial statements, including statements of operations, balance sheets, and cash flows, for the three and six months ended June 30, 2025, with accompanying notes [Consolidated Statements of Operations](index=6&type=section&id=Consolidated%20Statements%20of%20Operations) The company reported significant growth in net income for both the three and six-month periods ended June 30, 2025, compared to the prior year, driven by increased net revenue and improved operating income Consolidated Statements of Operations Highlights (in thousands, except per share amounts) | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | :--- | :--- | | **Net revenue** | $724,508 | $701,780 | $1,419,928 | $1,360,971 | | **Gross profit** | $286,253 | $249,947 | $542,144 | $488,007 | | **Operating income** | $111,372 | $95,470 | $211,719 | $84,724 | | **Net income (loss) attributable to Amneal** | $22,417 | $5,994 | $34,612 | $(85,649) | | **Diluted EPS** | $0.07 | $0.02 | $0.11 | $(0.28) | [Consolidated Balance Sheets](index=10&type=section&id=Consolidated%20Balance%20Sheets) As of June 30, 2025, total assets decreased slightly to $3.42 billion from $3.50 billion at year-end 2024, primarily due to reductions in intangible assets and cash, while total liabilities also decreased Consolidated Balance Sheet Highlights (in thousands) | Account | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Cash and cash equivalents | $71,544 | $110,552 | | Total current assets | $1,584,692 | $1,587,806 | | Total assets | $3,422,788 | $3,501,445 | | Revolving credit facility | $290,000 | $100,000 | | Total long-term debt, net | $2,146,403 | $2,161,790 | | Total liabilities | $3,469,519 | $3,545,983 | | Total stockholders' deficiency | $(112,533) | $(109,512) | [Consolidated Statements of Cash Flows](index=11&type=section&id=Consolidated%20Statements%20of%20Cash%20Flows) For the six months ended June 30, 2025, net cash provided by operating activities significantly increased, while net cash used in investing and financing activities also rose Consolidated Cash Flow Summary (in thousands) | Cash Flow Activity | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | | Net cash provided by operating activities | $91,227 | $35,247 | | Net cash used in investing activities | $(44,345) | $(26,225) | | Net cash used in financing activities | $(80,853) | $(58,241) | | **Net decrease in cash, cash equivalents, and restricted cash** | **$(34,748)** | **$(49,485)** | [Notes to Consolidated Financial Statements](index=18&type=section&id=Notes%20to%20Consolidated%20Financial%20Statements) The notes provide detailed information on significant accounting policies, financial statement accounts, revenue disaggregation, debt refinancing, and legal proceedings, including the opioid litigation settlement - Revenue is highly concentrated, with three customers (A, B, and C) accounting for **23%**, **16%**, and **21%** of total net revenue, respectively, for the first six months of 2025[39](index=39&type=chunk) - In January 2025, the company paid the entire remaining principal balance of **$192.0 million** on its Term Loan Due 2025 using borrowings from its revolving credit facility and cash on hand[65](index=65&type=chunk) - The company reached a nationwide settlement in principle for opioid cases, agreeing to pay **$92.5 million** in cash over ten years and provide **$180.0 million** in naloxone nasal spray, with a **$94.4 million** charge recorded in Q1 2024, bringing the total liability to **$114.5 million** as of June 30, 2025[91](index=91&type=chunk)[92](index=92&type=chunk) - Subsequent to the quarter end, on August 1, 2025, the company refinanced its debt by issuing **$600 million** in senior secured notes due 2032 and borrowing **$2.1 billion** in new term loans due 2032 to repay its existing Term Loan Due 2028 and revolving credit facility borrowings[133](index=133&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=41&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management analyzes the company's financial performance for the three and six months ended June 30, 2025, detailing revenue growth drivers, segment performance, gross margin trends, operating expenses, and liquidity, including recent debt refinancing [Results of Operations](index=42&type=section&id=Results%20of%20Operations) For Q2 2025, net revenue grew 3.2% to $724.5 million, and gross margin improved to 39.5%, leading to a 16.7% increase in operating income, while the six-month period saw 4.3% revenue growth and a significant rise in operating income Consolidated Results - Three Months Ended June 30 (in thousands) | Metric | 2025 | 2024 | Change % | | :--- | :--- | :--- | :--- | | Net revenue | $724,508 | $701,780 | 3.2% | | Gross profit | $286,253 | $249,947 | 14.5% | | Operating income | $111,372 | $95,470 | 16.7% | Consolidated Results - Six Months Ended June 30 (in thousands) | Metric | 2025 | 2024 | Change % | | :--- | :--- | :--- | :--- | | Net revenue | $1,419,928 | $1,360,971 | 4.3% | | Gross profit | $542,144 | $488,007 | 11.1% | | Operating income | $211,719 | $84,724 | nm | - Key drivers for revenue growth included new product launches in the Affordable Medicines segment (**$33.0 million** in Q2, **$73.8 million** in H1) and increased sales of CREXONT®, RYTARY®, and UNITHROID® in the Specialty segment[149](index=149&type=chunk)[174](index=174&type=chunk) [Segment Performance Analysis](index=43&type=section&id=Segment%20Performance%20Analysis) In Q2 2025, Affordable Medicines revenue increased by 1.4% due to new products, Specialty revenue grew 23.1% from strong brand performance, and AvKARE's operating income rose 65.3% despite a 4.3% revenue decrease due to a favorable product mix - **Affordable Medicines:** Q2 revenue grew **1.4%** to **$433.4 million**, with operating income up **1.1%** to **$102.4 million**, driven by **$33.0 million** in new product contributions[155](index=155&type=chunk)[156](index=156&type=chunk) - **Specialty:** Q2 revenue grew **23.1%** to **$128.0 million**, primarily from increases in CREXONT® (**$11.2 million**), RYTARY® (**$9.0 million**), and UNITHROID® (**$3.7 million**), leading to a **32.2%** rise in operating income to **$35.5 million**[160](index=160&type=chunk)[161](index=161&type=chunk) - **AvKARE:** Q2 revenue decreased **4.3%** to **$163.0 million**, but operating income increased **65.3%** to **$18.1 million** due to a favorable shift from low-margin distribution to higher-margin government label sales[166](index=166&type=chunk)[167](index=167&type=chunk) [Liquidity and Capital Resources](index=49&type=section&id=Liquidity%20and%20Capital%20Resources) The company's liquidity is primarily derived from operations and debt financing, with a recent major debt refinancing completed post-quarter to extend maturities and repay existing obligations - The company believes its current liquidity is sufficient to fund operations, interest, and contractual obligations for the next 12 months[198](index=198&type=chunk) - On August 1, 2025, the company refinanced its debt, issuing **$600 million** in 6.875% senior secured notes due 2032 and borrowing **$2.1 billion** in new term loans due 2032 to repay its Term Loan Due 2028 and revolving credit facility[207](index=207&type=chunk) - Net cash from operating activities for the first six months of 2025 was **$91.2 million**, a significant increase from **$35.2 million** in the prior year, primarily due to a **$52.4 million** litigation settlement payment made in 2024[211](index=211&type=chunk)[212](index=212&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=52&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company reports no material changes in its assessment of market risk compared to the disclosures in its 2024 Annual Report on Form 10-K - There has not been any material change in the company's assessment of market risk as set forth in its 2024 Annual Report on Form 10-K[220](index=220&type=chunk) [Item 4. Controls and Procedures](index=52&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that the company's disclosure controls and procedures were effective as of June 30, 2025, with no material changes to internal control over financial reporting during the quarter - The Co-Chief Executive Officers and Chief Financial Officer concluded that the company's disclosure controls and procedures were effective as of June 30, 2025[222](index=222&type=chunk) - No material changes were made to internal control over financial reporting during the quarter ended June 30, 2025[223](index=223&type=chunk) [PART II - OTHER INFORMATION](index=53&type=section&id=PART%20II%20-%20OTHER%20INFORMATION) This section addresses legal proceedings, risk factors, and other miscellaneous disclosures, including equity sales, senior security defaults, and exhibits [Item 1. Legal Proceedings](index=53&type=section&id=Item%201.%20Legal%20Proceedings) This section incorporates by reference the detailed information regarding legal proceedings found in Note 16. Commitments and Contingencies of the financial statements - Information regarding legal proceedings is detailed in Note 16. Commitments and Contingencies within the financial statements[225](index=225&type=chunk) [Item 1A. Risk Factors](index=53&type=section&id=Item%201A.%20Risk%20Factors) The company reports no material changes to the risk factors previously disclosed in its 2024 Annual Report on Form 10-K - There have been no material changes to the risk factors disclosed in the company's 2024 Annual Report on Form 10-K[226](index=226&type=chunk) [Other Items (Items 2, 3, 4, 5, 6)](index=53&type=section&id=Other%20Items%20(Items%202%2C%203%2C%204%2C%205%2C%206)) This section confirms no unregistered sales of equity securities, no defaults upon senior securities, and no other material information to report under Item 5, with Item 6 listing the exhibits filed - The report indicates no activity for Item 2 (Unregistered Sales of Equity Securities), Item 3 (Defaults Upon Senior Securities), and Item 5 (Other Information)[227](index=227&type=chunk)[228](index=228&type=chunk)[229](index=229&type=chunk)

Core Insights - Amneal Pharmaceuticals reported revenue of $724.51 million for the quarter ended June 2025, marking a year-over-year increase of 3.2% [1] - The earnings per share (EPS) for the same period was $0.25, compared to $0.16 a year ago, indicating a significant improvement [1] - The reported revenue was slightly below the Zacks Consensus Estimate of $725.6 million, resulting in a surprise of -0.15% [1] - The company achieved an EPS surprise of +38.89%, with the consensus EPS estimate being $0.18 [1] Revenue Breakdown - Affordable Medicines Segment generated net revenue of $433.43 million, which was below the average estimate of $453.34 million, reflecting a year-over-year change of +1.4% [4] - AvKARE Segment reported net revenue of $163.04 million, falling short of the estimated $182.65 million, representing a year-over-year decline of -4.3% [4] - Specialty Segment achieved net revenue of $128.04 million, exceeding the average estimate of $108.11 million, with a year-over-year increase of +23.1% [4] Stock Performance - Over the past month, Amneal's shares have returned -5.4%, contrasting with the Zacks S&P 500 composite's +1% change [3] - The stock currently holds a Zacks Rank 2 (Buy), suggesting potential for outperformance in the near term [3]

Financial Data and Key Metrics Changes - In Q2 2025, Amneal Pharmaceuticals reported revenues of $720 million, with adjusted EBITDA of $184 million, reflecting a 3% revenue growth and a 13% increase in adjusted EBITDA year-over-year [5][24][28] - Adjusted EPS grew by 56%, driven by higher adjusted EBITDA, favorable foreign exchange, and lower interest expenses [28] - The company reduced net leverage to 3.7x from 3.9x adjusted EBITDA in December 2024, fully refinancing its debt to lower interest costs and extend maturities to February 2032 [24][25][31] Business Line Data and Key Metrics Changes - Affordable medicines revenue was $433 million, growing 1% year-over-year, supported by new product launches adding $33 million [25][26] - Specialty revenue reached $128 million, a 23% increase year-over-year, driven by key branded products like Krexan, Rytary, and Unithroid [26][27] - AvKARE revenues declined by 4%, but gross margin increased by 540 basis points, and operating income rose by 44% [27] Market Data and Key Metrics Changes - The U.S. market share for Krexan is approximately 2%, with expectations to exceed 3% by year-end [8] - The biosimilars market is projected to see significant growth due to an increase in biologic patent expirations, with Amneal anticipating six marketed biosimilars by 2027 [13][21] Company Strategy and Development Direction - Amneal is transitioning from generics to innovative and complex medicines, focusing on growth drivers such as Trexor for Parkinson's disease and the Breqya Auto injector for migraines [6][10] - The company aims to be America's number one affordable medicines company, with a strategic goal to enhance its portfolio through new product launches and partnerships [14][32] - Amneal is investing in manufacturing capabilities, including a collaboration with EpiJet for U.S. injectable manufacturing, to support future complex product launches [17][19] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's growth trajectory, citing strong performance in specialty products and a robust pipeline of new launches [5][24] - The company anticipates a stronger second half of 2025, driven by new product introductions and improved manufacturing capabilities [63] - Management is closely monitoring potential tariff impacts but believes their U.S.-based manufacturing footprint mitigates risks [66][70] Other Important Information - Amneal plans to launch 20 to 30 new products annually, with 15 new products already launched in 2025 [19] - The company has 76 ANDAs pending approval, with a focus on non-oral solid products [20] - Amneal's strategic partnerships, particularly with MedCera, are expected to enhance profitability and expand market reach [40][41] Q&A Session Summary Question: Status of Krexan and Rytary in the Parkinson's franchise - Management indicated that Rytary's generic competition has not yet been approved, allowing for stable revenue this year, with expectations of a revenue trough next year due to increased competition [36][38] Question: Profitability of Metcera collaboration - Management expects higher margins from the Metcera collaboration due to upfront risk taken in building manufacturing sites, with significant market opportunities anticipated in international markets [40][41] Question: Update on Rytary generic launches and reimbursement status - Teva holds a 180-day exclusivity on the generic Rytary, which has not yet been approved, but management remains optimistic about future growth and reimbursement coverage for Crexan [46][48][50] Question: Drivers of revenue guidance for the second half of 2025 - Management expects stronger revenue in the second half due to new product launches and completed facility upgrades that enhance supply capabilities [62][63] Question: Thoughts on potential vertical integration of the biosimilars business - Management is focused on executing quickly in the biosimilars market while maintaining a disciplined approach to capital allocation and debt management [74][80]

Financial Data and Key Metrics Changes - In Q2 2025, total net revenues increased by 3% to $720 million, with adjusted EBITDA growing by 13% to $184 million and adjusted EPS rising by 56% [23][24][27] - For the first half of 2025, total company revenues grew by 4%, adjusted EBITDA increased by 12%, and adjusted EPS rose by 50% [27][30] Business Line Data and Key Metrics Changes - Affordable medicines revenue was $433 million, growing by 1% year-over-year, driven by new product launches adding $33 million [23][24] - Specialty revenue reached $128 million, a 23% increase year-over-year, with key products like Krexan contributing significantly [24][25] - AvKARE revenues declined by 4%, but gross margin increased by 540 basis points, and operating income rose by 44% [25][26] Market Data and Key Metrics Changes - The U.S. market share for Krexan is approximately 2%, with expectations to exceed 3% by year-end [6] - The biosimilars market is projected to see significant growth due to an increase in biologic patent expirations, with Amneal anticipating six marketed biosimilars by 2027 [11][20] Company Strategy and Development Direction - Amneal is transitioning from generics to innovative and complex medicines, focusing on specialty products and biosimilars as key growth drivers [5][6] - The company aims to be America's number one affordable medicines company, with a strategic goal to enhance access and care for patients [12][21] - Amneal is investing in manufacturing capabilities and partnerships, such as with MedCera, to expand its product offerings and market reach [9][17] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the growth trajectory, citing strong performance in specialty products and a robust pipeline of new launches [4][10] - The company is optimistic about the impact of new federal tax legislation, expecting approximately $46 million in tax savings, primarily from R&D expensing [30][31] Other Important Information - Amneal has fully refinanced $2.7 billion of debt, reducing interest costs and extending maturities to 2032 [30] - The company plans to launch 20 to 30 new products annually, with 15 new products already launched in 2025 [18][19] Q&A Session Summary Question: Status of Krexan and Rytary in the Parkinson's franchise - Management indicated that Rytary has not yet seen generic competition, which is beneficial for revenue this year, with expectations for a trough in revenue next year due to increased competition [34][36] Question: Profitability of MetCera collaboration - The collaboration is structured to provide higher margins than typical CMO or CDMO arrangements, with significant opportunities in international markets [38][39] Question: Update on Rytary generic launches and reimbursement status - Teva holds exclusivity on the generic Rytary, and commercial coverage for Crexan has exceeded expectations, currently at over 60% [44][49] Question: Drivers of revenue guidance for the second half - The company expects stronger revenue in the second half due to new product introductions and completed facility upgrades that enhance supply capabilities [63][64] Question: Thoughts on tariffs and their impact on the industry - Management discussed the potential chaos from high tariffs and emphasized the importance of U.S. manufacturing to mitigate risks [67][70] Question: Vertical integration of the biosimilars business - The company is focused on executing quickly in the biosimilars market while maintaining a disciplined approach to capital allocation [76][81]

Financial Performance & Growth - Q2 2025 revenue reached $725 million, a 3% increase compared to Q2 2024[5] - Adjusted EBITDA for Q2 2025 was $184 million, up 13% from Q2 2024[5] - Adjusted EPS for Q2 2025 increased by 56% to $025, compared to $016 in Q2 2024[5] - The company is increasing its 2025 adjusted EBITDA guidance range to $665 million - $685 million[5] - Net revenues are projected to be between $30 billion and $31 billion in 2025, representing a 7% to 11% increase[11] Segment Performance - Specialty segment revenue increased by 13% in the first half of 2025[5] - Affordable Medicines segment revenue increased by 4% in the first half of 2025[5] - AvKARE segment revenue increased by 1% in the first half of 2025[5] - AvKARE revenue reached $663 million in 2024, with a 23% compound annual growth rate (CAGR) from 2020 to 2024, and is projected to exceed $900 million by 2027[24] Product & Pipeline Development - CREXONT is on track to achieve peak U S sales of $300 million to $500 million[39] - The company expects to file a Biologics License Application (BLA) for an omalizumab biosimilar (bXOLAIR) in Q4[5] - The company launched 15 new products in the Affordable Medicines portfolio year-to-date[5]

Core Viewpoint - Amneal Pharmaceuticals reported quarterly earnings of $0.25 per share, exceeding the Zacks Consensus Estimate of $0.18 per share, and showing an increase from $0.16 per share a year ago, indicating a strong earnings surprise of +38.89% [1] Financial Performance - The company posted revenues of $724.51 million for the quarter ended June 2025, slightly missing the Zacks Consensus Estimate by 0.15%, but showing growth from $701.78 million year-over-year [2] - Over the last four quarters, Amneal has surpassed consensus EPS estimates three times and topped consensus revenue estimates two times [2] Stock Performance and Outlook - Amneal shares have increased by approximately 0.5% since the beginning of the year, underperforming compared to the S&P 500's gain of 7.6% [3] - The company's earnings outlook is crucial for investors, as it includes current consensus earnings expectations for upcoming quarters and any recent changes to these expectations [4] Earnings Estimate Revisions - The trend for estimate revisions for Amneal was favorable ahead of the earnings release, resulting in a Zacks Rank 2 (Buy) for the stock, suggesting expected outperformance in the near future [6] - The current consensus EPS estimate for the upcoming quarter is $0.17 on revenues of $783.57 million, and for the current fiscal year, it is $0.71 on revenues of $3.02 billion [7] Industry Context - The Medical - Drugs industry, to which Amneal belongs, is currently ranked in the top 37% of over 250 Zacks industries, indicating a favorable outlook compared to the bottom 50% [8]